Erwinase 10,000unit powder for solution for injection vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Crisantaspase

Boleh didapati daripada:

Porton Biopharma Ltd

Kod ATC:

L01XX02

INN (Nama Antarabangsa):

Crisantaspase

Dos:

10000unit

Borang farmaseutikal:

Powder for solution for injection

Laluan pentadbiran:

Intravenous; Intramuscular; Subcutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 08010500; GTIN: 05056261700017

Risalah maklumat

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERWINASE®
10,000 Units, Powder for solution for injection
(Asparaginase from
_Erwinia chrysanthemi_
;
_Erwinia_
L-asparaginase)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Erwinase is and what it is used for
2.
What you need to know before you receive Erwinase.
3.
How to receive Erwinase
4.
Possible side effects
5.
How to store Erwinase
6.
Contents of pack and other information
1.
WHAT ERWINASE IS AND WHAT IT IS USED FOR
HOW DOES ERWINASE WORK
Erwinase is an anti-blood-cell-cancer treatment. It works by lowering
the levels of asparagine in your body,
a substance the cancer cells need to survive.
WHAT THIS MEDICINE IS USED FOR
Erwinase is used for the treatment of a cancer of the white blood
cells called Acute Lymphoblastic
Leukaemia. It may also be used to treat other cancers where lower
levels of asparagine might have a useful
effect.
Erwinase may be used alone or with other treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ERWINASE
YOU SHOULD NOT RECEIVE ERWINASE IF :
■
you are allergic (hypersensitive) to the active substance (
_Erwinia _
L-asparaginase) or any of the other
ingredients of Erwinase (see section 6).
■ you have had a bad reaction to treatment with Erwinase on a
previous occasion.
■ you have history of pancreas problems (acute pancreatitis).
■ you are pregnant or trying to get pregnant.
■ you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Erwinase.
Your body may become sensitive to the active substance after repeated
treatments. It could be the cause of
allergic reactions (see section 4. Po

Ciri produk

OBJECT 1
ERWINASE (ERWINIA L-ASPARAGINASE), 10,000
UNITS/VIAL, LYOPHILISATE FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 23-Feb-2017 | Jazz
Pharmaceuticals UK
1. Name of the medicinal product
ERWINASE
®
, 10,000 Units/vial, Lyophilisate for solution for injection.
2. Qualitative and quantitative composition
Crisantaspase (Asparaginase from _Erwinia chrysanthemi_; _Erwinia
_L-asparaginase), 10,000 Units/vial.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Lyophilisate for solution for injection.
White lyophilised powder in a vial.
4. Clinical particulars
4.1 Therapeutic indications
Erwinase is used in combination with other anti-neoplastic agents to
treat acute lymphoblastic leukaemia.
It may also be used in other neoplastic conditions where depletion of
asparagine might be expected to
have a useful effect. Patients receiving treatment with L-asparaginase
from _Escherichia coli_, and who
develop hypersensitivity to that enzyme may be able to continue
treatment with Erwinase as the enzymes
are immunologically distinct.
4.2 Posology and method of administration
Posology
For all patients the usual dose is 6,000 Units/m2 body surface area
(200 Units/kg of body weight), three
times a week for three weeks. Therapy may be further intensified
according to protocol.
Reference to current Medical Research Council protocols on leukaemia
therapy should be made for
information on dose, route and frequency of treatment.
Method of administration
Erwinase solution can be given by intravenous injection or by
intramuscular or subcutaneous injection.
4.3 Contraindications
Previous allergic reaction to _Erwinia _asparaginase.
Previous episode of acute pancreatitis related to L-asparaginase
therapy.
Breast-feeding (see section 4.6).
4.4 Special warnings and precautions for use
Warnings: Anaphylactic reactions have been observed after the use of
Erwinase. Facilities should be
made available for management of an anaphylactic reaction, should it
occur, during administration.
Careful observ